Berlin Metropolitan Area
Regulatory affairs professional with over 20 years of experience in global clinical and CMC regulatory strategy, thereof more than ten years in leadership functions. Responsibility for small molecule, biotech and combination products from clinical phase I to the end of the product lifecycle. Proven track record of submissions across regulatory procedures, including successful conduct of health authority meetings. PhD on traditional Chinese plant "Atractylodes lancea" (苍术). I love to contribute to improving patients' lives, and to challenge the status quo for the better.
Senior Advisor and Mentor for the regulatory affairs CMC function
Leading diverse groups of up to 25 Regulatory CMC Experts, partially with subgroups who handle small molecule, biotech and combination projects and products, from development to first marketing and beyond. Various cross-functional responsibilies and projects to foster cooperation, ensure compliance, and address emerging regulatory requirements (specific focus on EU, Chinese and Korean regulatory requirements).
Global Regulatory Lead for initial NDA/MAA submissions and accelerated approval procedures of oncology drug Xofigo (approvals e. g. USA 15 May 2013, EU 11 Nov. 2013, Canada 12 Dec. 2013).